A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
- Conditions
- HBeAg-Positive or HBeAg-Negative Chronic Hepatitis Binfection of the liver10047438
- Registration Number
- NL-OMON39436
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Adult subjects (aged 18-75) with CHB (e.g., positive for either serum HBsAg or HBV DNA for at least 6 months) prior to baseline.;Anti-HBV treatment naïve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose greater than or equal to 24 weeks prior to screening are also eligible.;HBV DNA for HBeAg- >= 2000 IU/ml, and HBeAg+ subjects >= 20000 IU/ml.;ALT > 54 U/L and <= 400 U/L for men, and > 36 U/L and <= 300 U/L for women.;Creatinine clearance rate greater than or equal to 80 mL/min
Known bridging fibrosis or cirrhosis and/or decompensated liver disease;Decompensated liver disease;Absolute neutrophil count < 1,500/mm3, platelet < 100,000/mm3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male).;Evidence of hepatocellular carcinoma;Histroy of significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures);History of severe depression or severe psychiatric disease;Thyroid dysfunction;Co-infection with HIV, HCV or HDV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is:<br /><br>• The proportion of subjects with HBsAg loss at Week 72 following treatment<br /><br>with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF<br /><br>alone</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary:<br /><br>• The proportion of subjects with HBsAg loss at Week 72 following treatment<br /><br>with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48<br /><br>weeks or TDF alone<br /><br>• The proportion of subjects who experience HBsAg loss at Week 96 and Week 120<br /><br>• The proportion of subjects with virological response (HBV DNA level < 117<br /><br>IU/mL) at Weeks 72, 96, and 120<br /><br>• The proportion of subjects with serological response (HBeAg loss and<br /><br>seroconversion, and HBsAg seroconversion) at Weeks 72, 96 and 120<br /><br>• The proportion of subjects who experience biochemical response (ALT < 30 for<br /><br>males and < 19 for females (based on AASLD 2008 guidelines); ALT < 42 for males<br /><br>and < 32 for females (based on central lab ULN for ALT) at Weeks 72, 96, and 120<br /><br>• The proportion of subjects who require re-initiation or change of therapy<br /><br>while on therapy or post-treatment<br /><br></p><br>